Quality Assurance Specialist – CMC (Chemistry, Manufacturing & Controls)
Vyriad is an early stage biotechnology company focused on curing cancer using potent, safe and cost-effective cancer therapies utilizing engineered replication competent viruses designed to selectively and rapidly destroy cancer. Revolutionizing cancer treatment is our long-term goal, requiring curiosity, perseverance, an openness to challenging convention and a commitment to excellence. The challenges are complex, the work pace is fast, and progress is seldom a straight line. All of this makes for an exhilarating environment of collaboration, discovery and fun.
Quality Assurance staff are responsible for oversight of quality and regulatory compliance for product manufacturing activities. Staff work to identify and reduce regulatory and compliance risk by continuous monitoring and evaluating facility policies and practices to ensure compliance is built into the operational systems. Quality Assurance staff communicate and work effectively with leadership to take necessary actions to mitigate identified risks.
Quality Assurance staff are accountable for the effective implementation of the Quality Management System (QMS) and serves as the subject matter expert on the policies, processes and procedures of the QMS by developing a broad knowledge of the practice, business and technology as it relates to product manufacturing.
- Develop and oversee the product manufacturing compliance program.
- Monitor operations in the production rooms.
- Provide direct QA support during manufacturing operations.
- Work with manufacturing staff to ensure compliance with regulatory requirements associated with internal and external assessments and responses to citations.
- Develop regulatory and compliance training program for the intended audience. Maintain program and keep it up to date.
- Perform review of product manufacturing documents for clarity and compliance with regulatory requirements.
- Ensure compliance concerns are prioritized and resources identified.
- Ensure product manufacturing service risks are escalated to management.
- Develop CMC expertise related to Vyriad manufacturing and ensure change management activities are in place to support reporting requirements for regulatory filings.
- Coordinate CMC reviews and submissions for GMP manufacturing.
- Maintain CMC files.
- Leads the investigation of events that appear to be associated with regulatory violations. Works with relevant parties to resolve issue and take appropriate corrective and preventive action.
- A bachelor’s degree in a science related field is required and a minimum of 2 years’ experience in a manufacturing quality control/quality assurance role.
Experience and skill requirement:
- Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing is required. Additional experience with other requirements (Good Laboratory Practices, ISO, etc.) is highly desirable.
- Exceptional human relations and communication (written, verbal, and listening) skills are required. Should be very detail-oriented and have the ability to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment.
- Strong analytic skills coupled with critical thinking skills are essential in this role. Must have demonstrated capacity to comprehend complex protocols, programs, and situations. The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required. Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.
Monday-Friday 8:00 – 5:00
Rochester, MN (Required)
Work visa sponsorship is not available for this position.
Compensation and benefits:
Salary is commensurate with experience and qualifications. A comprehensive benefits package including:
- Paid Holidays
- Employer paid Short- and Long-Term Disability
- Life Insurance
- Dental Insurance
- Simple IRA with an employer match
How to apply
To apply please send a resume and cover letter to firstname.lastname@example.org. References will be requested and background checks will be required prior to start of employment. Applications will be reviewed as received until the position is filled.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Vyriad is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.